Phase 3 Huntington's Disease Trial, By Invitation (NCT07537075)

Phase 3 Huntington's Disease Trial, By Invitation NCT07537075 Sponsor: Skyhawk Therapeutics, Inc. Condition: Huntington's Disease

Printed from Voxsanity (voxsanity.com.au) — NCT07537075 — Data sourced from ClinicalTrials.gov. Verify directly with the trial site before attending. Not medical advice.

Back to Huntingtons Disease

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

You must have already completed treatment in a previous SKY-0515 treatment study, and the study doctor must feel you followed that study's rules and procedures properly.
You must be able and willing to follow all the requirements of this study, as judged by the study doctor.
You must be able to tolerate having blood drawn during the study.
You must be willing and able to attend all scheduled appointments, follow the treatment plan, and complete all tests and other study activities.
Women who are able to become pregnant must have a negative pregnancy test before starting the study, and must use two forms of birth control during the study and for 30 days after the last dose of the study drug.
Men must agree to use birth control during the study and for 90 days after the last dose of the study drug.

Who may not be able to join:

People who have any other health conditions or circumstances that, in the opinion of the study doctor or the study sponsor, would make it unsafe or unsuitable for them to participate, or that could affect their ability to complete the study (confirm with trial site).

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.

Last synced 28 July 2026

Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.

Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Australian sites

John Hunter Hospital, New Lambton Heights, New South Wales

Westmead Hospital, Westmead, New South Wales

The University of Queensland, Herston, Queensland

Flinders Medical Centre, Adelaide, South Australia

Calvary Health Care Bethlehem, Caulfield South, Victoria

The Royal Melbourne Hospital, Parkville, Victoria

The Perron Institute for Neurology and Translational Science (Perron Institute), Nedlands, Western Australia

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Voxsanity

Clinical trials and treatments, explained plainly · voxsanity.com.au

Date:

To: My Doctor

Re: Clinical trial enquiry

I am writing to enquire about the following clinical trial which may be relevant to my care:

Trial: NCT07537075

Sponsor: Skyhawk Therapeutics, Inc.

Phase: Phase 3

Status: By Invitation

Condition: Huntington's Disease

More information: https://clinicaltrials.gov/study/NCT07537075

Eligibility summary (AI generated)

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

You must have already completed treatment in a previous SKY-0515 treatment study, and the study doctor must feel you followed that study's rules and procedures properly.
You must be able and willing to follow all the requirements of this study, as judged by the study doctor.
You must be able to tolerate having blood drawn during the study.
You must be willing and able to attend all scheduled appointments, follow the treatment plan, and complete all tests and other study activities.
Women who are able to become pregnant must have a negative pregnancy test before starting the study, and must use two forms of birth control during the study and for 30 days after the last dose of the study drug.
Men must agree to use birth control during the study and for 90 days after the last dose of the study drug.

Who may not be able to join:

People who have any other health conditions or circumstances that, in the opinion of the study doctor or the study sponsor, would make it unsafe or unsuitable for them to participate, or that could affect their ability to complete the study (confirm with trial site).

Important: Always verify eligibility with the trial site directly before applying.

Access in Australia: A treatment being studied in a clinical trial is generally not yet listed on the PBS. Where a medicine is not approved or not available through a trial, the TGA Special Access Scheme may allow a doctor to access unapproved therapeutic goods for individual patients. See voxsanity.com.au/sas-navigator/ for a plain English explainer.

This information was sourced from ClinicalTrials.gov via Voxsanity (data last synced 28 July 2026). It is not medical advice. Please verify the trial's current status directly with the trial site before acting.

Trial details

Status

By Invitation

Phase

Phase 3

Sponsor

Skyhawk Therapeutics, Inc.

Registry

ClinicalTrials.gov

Start date

10 April 2026

Est. completion

1 December 2029

Where this trial is recruiting

🇦🇺 Australia 🇳🇿 New Zealand

7 site(s) in Australia. Confirm current status and contact details directly with the trial site.

Primary endpoints

Long-term safety and tolerability of SKY-0515

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov